{"groups":[{"description":"Participants were accrued at 50 mg/m\\^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m\\^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"FG000","title":"Phase II: 50 mg/m^2"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Protocol Violation"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"16"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"15"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Of the 10 participants accrued in the Phase II portion of the study, one was excluded for protocol violation. The 6 participants treated in the Safety Analysis Phase at the 50 mg/m\\^2 dose level (after the protocol amendment) are included in the Phase II analysis. Therefore, this Phase II analysis is based on 15 evaluable participants.","recruitmentDetails":"From 7/2009 to 12/2011, 29 participants were accrued. The study opened at 50 mg/m\\^2, accrued 2, and closed for safety review and protocol amendment. The study reopened with a dose escalation phase and accrued 4 at 30 mg/m\\^2 dose, 7 at 40 mg/m\\^2 dose, and 6 at 50 mg/m\\^2 dose. The Phase II dose level was set at 50 mg/m\\^2 and accrued 10 participants."}